Managing Anxiety From Cancer (MAC): Testing an Intervention for Anxiety in Older Adults With Cancer and Their Caregivers

This study is a pilot randomized controlled trial of a seven-session telephone-administered
cognitive-behavioral therapy (CBT) intervention for anxiety in older adults with cancer and
their primary informal (unpaid) caregiver. The primary purpose of this study is to examine
the impact of the intervention on patient and caregiver anxiety, depression, distress, and
quality of life relative to a usual care control condition. Anxiety is the primary outcome;
depression, distress, and quality of life are secondary outcomes. Patients will be 65 years
of age or older and will be recruited from the myeloma, lung, lymphoma, gynecologic, breast,
and genitourinary cancer clinics at a single institution. Study measures will be administered
by telephone prior to initiating the intervention (baseline) and following intervention
completion for participants in the treatment condition or 8-9 weeks after the baseline survey
for participants in the usual care condition (follow-up).

Inclusion Criteria:

PATIENTS:

- Age 65 or older

- Confirmed diagnosis of breast, lymphoma, prostate, lung, or gynecological cancer,
currently on active treatment or within six months of completion of treatment

- English fluent (as per self-reported fluency of "very well")**

- In the judgment of the investigators and/or consenting professional, able to perform
informed consent

- Has a primary informal caregiver (as defined by an unpaid individual who provides the
patient with emotional, physical, and/or practical support) who is willing and able to
participate in the study

- As part of the patient-caregiver dyad, at least one member reports elevated anxiety as
defined by a score of 8 or greater on the anxiety subscale of the Hospital Anxiety and
Depression Scale (HADS)

- As per self-report, residency in New York or ability to complete sessions in New York

- Able to communicate over the phone for sessions

- Willingness to be audio-recorded for assessments and, if applicable, study sessions

CAREGIVERS:

- Age 21 or older

- As determined by the patient‟s primary oncologist and/or study staff, physically and
cognitively able to complete study procedures

- In the judgment of the investigators and/or consenting professional, able to perform
informed consent

- As part of the patient-caregiver dyad, at least one member reports elevated anxiety as
defined by a score of 8 or greater on the anxiety subscale of the Hospital Anxiety and
Depression Scale (HADS)

- English fluent (as per self-reported fluency of "very well")**

- Is a primary informal caregiver (as defined by an unpaid individual who provides the
patient with emotional, physical, and/or practical support) for an MSK patient

- As per self-report, residency in New York or ability to complete sessions in New York

- Able to communicate over the phone for sessions

- Willingness to be audio-recorded for assessments and, if applicable, study sessions

Exclusion Criteria:

PATIENTS:

- Endorsing active suicidal ideation on the item, "In light of your current
circumstances, have you ever had thoughts of killing yourself?"

- As per oncologist or self-report, too weak or cognitively impaired to participate in
the intervention and complete the assessments

- Per self-report/screening measures, has received cognitive-behavioral therapy since
cancer diagnosis

- As per medical record or self-report, currently being treated for schizophrenia,
substance use or dependence, and/or bi-polar disorder

- Anxiety due solely to a medical procedure as determined by a patient-report item on
the screening questionnaire

CAREGIVERS:

- Endorsing active suicidal ideation on the item, "In light of your current
circumstances, have you ever had thoughts of killing yourself?"

- Per self-report/screening measures, has received cognitive-behavioral therapy since
patient‟s cancer diagnosis

- As per self-report, currently being treated for schizophrenia, substance use or
dependence, and/or bi-polar disorder

- If female, currently pregnant